Proleukin (aldesleukin)

Proleukin injection contains the active ingredient aldesleukin, which is a type of medicine called an immunomodulator. Aldesleukin is a synthetic version of a protein molecule called interleukin-2 (IL-2) that is produced naturally by the body's immune system. IL-2 is produced by white blood cells called T-lymphocytes.

12/06/2012

What is it used for?

Kidney cancer that has spread to other parts of the body (metastatic renal cell carcinoma).

Acute myeloid leukaemia in adults. This medicine is used in combination with another medicine called histamine (Ceplene), as a maintenance treatment to help prevent the disease relapsing after treatment with chemotherapy has brought the leukaemia into remission.

Aldesleukin may also be used in clinical trials for the treatment of other types of cancer, such as skin cancer (malignant melanoma).

How does it work?

Proleukin injection contains the active ingredient aldesleukin, which is a type of medicine called an immunomodulator. Aldesleukin is a synthetic version of a protein molecule called interleukin-2 (IL-2) that is produced naturally by the body's immune system. IL-2 is produced by white blood cells called T-lymphocytes.

IL-2 is released by T-lymphocytes when they detect a foreign substance in the body. It stimulates a rapid increase in the number of T-lymphocytes and other white blood cells called natural killer cells. These are some of the immune cells responsible for regulating and triggering immune responses. They help defend the body by attacking bacteria and foreign or abnormal cells.

Cancers form when some cells within the body multiply in an abnormal and uncontrolled way. Broadly speaking there are two main types of cancer; solid cancers where a tumour forms, for example in the kidneys, and leukaemias and lymphomas where the blood cells divide and multiply abnormally.

Other characteristics of cancer besides uncontrolled growth include the ability of the abnormal cells to invade other tissues next to them or to break away from the original site, travel through the blood or lymph, and establish a new cancer at a different site of the body. These are called metastases.

The way in which aldesleukin works in the treatment of cancers and leukaemias is not fully understood. However, because it mimics the effects of natural IL-2 in the body, it is thought to work by stimulating the immune system to attack the abnormal cells. The amount of IL-2 produced by the body is normally very small and this treatment greatly increases the amount in the body.

How is it given?

This treatment may be given as an injection under the skin (subcutaneous injection) or as a drip into a vein (intravenous infusion).

The type of injection, how often the injections are given and length of treatment course depends on the type of cancer being treated.

Subcutaneous injections are usually given as an outpatient and some people may be trained to administer the injections themselves. However, if you need high doses, a drip, or several days of injections at a time you may need to stay in hospital.

Warning!

This medicine may cause various side effects that could affect your ability to drive or operate machinary safely. If affected you should not drive or operate machinary until these wear off.

Before and during treatment with Proleukin you may need to have blood tests to monitor your kidney and liver function, levels of blood cells and levels of fluids and electrolytes (salts) in your blood. You may also need to have an electrocardiogram (ECG) to check the functioning of your heart and chest X-rays to check your heart and lungs.

Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.

You should also tell your doctor if you start to feel short of breath or are breathing faster than normal during your treatment.

If you feel extremely tired or sleepy while having treatment with this medicine it is important to tell your doctor straight away. Your treatment may need to be stopped.

Sexually active men and women must use an effective method of contraception to avoid getting pregnant or fathering a child while having treatment with this medicine.

The safety and effectiveness of this medicine for use in children have not been established. It is not recommended for use in children.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

There is no information available about the safety of this medicine during pregnancy. It is not recommended for use during pregnancy unless considered essential by your doctor and only if the potential benefit to the mother outweighs any potential risks to the developing baby. Seek further medical advice from your doctor.

Sexually active men and women must use an effective method of contraception to avoid getting pregnant or fathering a child while having treatment with this medicine.

It is not known if this medicine passes into breast milk. As it could potentially cause side effects in a nursing infant, mothers needing treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

Pain and inflammation at the injection site.

Fever and chills.

Feeling tired and generally unwell.

Weight gain due to fluid retention.

Nausea and vomiting.

Diarrhoea.

Sore mouth.

Loss of appetite.

Decreased blood pressure.

Dizziness.

Headache.

Sleepiness.

Decreased levels of red blood cells or platelets in the blood (anaemia or thrombocytopenia) - see warning section above.

Anxiety or confusion.

Increased heart rate or chest pain.

Shortness of breath.

Cough.

Skin reactions such as redness, itching, rash, scaling.

Decreased production of urine.

Common (affect between 1 in 10 and 1 in 100 people)

Difficulty swallowing.

Indigestion or constipation.

Feeling irritable, agitated or depressed.

Hallucinations.

Difficulty sleeping (insomnia).

Pins and needles or tingling sensations.

Fainting.

Problems with speech.

Infections of the lungs or airways.

Fluid on the lungs (pulmonary oedema).

Decreased levels of white blood cells in the blood (leucopenia).

Raised levels of sugar or potassium in the blood.

Hair loss.

Sweating.

Dehydration.

Eye inflammation (conjunctivitis).

Irregular heartbeats (arrhythmias).

Increased blood pressure.

Blood in the stools or urine, vomiting blood.

Pain in the muscles or joints.

Blue colour to the lips, tongue and skin due to oxygen deficiency in the blood (cyanosis).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

Underactivity or overactivity of the thyroid gland.

Convulsions.

Muscle weakness.

Loss of sense of taste.

Problems with the heart, such as heart failure, heart attack or enlargement of the heart.

Blood clots in the blood vessels (thrombosis).

Bleeding, including coughing up blood or nosebleeds.

Inflammation of the stomach (gastritis).

Kidney failure.

Rare (affect between 1 in 1000 and 1 in 10,000 people)

Diabetes.

Low blood sugar.

Disorder of the optic nerve, leading to problems with vision.

Inflammation of the pancreas (pancreatitis).

Obstruction in the gut.

Liver failure.

Blistering rash or a severe scaling and blistering skin reaction called Steven's-Johnson syndrome.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while having treatment with this one, to make sure that the combination is safe.

This medicine is not recommended for use in combination with vinblastine, dacarbazine or cisplatin.

Corticosteroids such as prednisolone may make this medicine less effective and so should be avoided wherever possible in people having treatment with Proleukin.

There may be an increased risk of side effects on the heart or muscles if this medicine is given via drip into a vein in combination with interferon alfa treatment.

There may be an increased risk of low blood pressure if aldesleukin is administered to people taking blood pressure lowering medicines (antihypertensives) such as beta-blockers.

There may be an increased risk of adverse effects on the kidney, liver, bone marrow or heart if this medicine is used with other medicines that can affect these areas.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain aldesleukin or interleukin-2 as the active ingredient.

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